Phase I/II Trial of Decitabine and Allogeneic Peripheral Blood Stem Cells Transplantation for Treatment of Relapse Post Allogeneic Bone Marrow Transplantation
OBJECTIVES: I. Determine the maximum tolerated dose of decitabine in patients with relapse
post allogenic bone marrow transplant. II. Determine the toxicity of decitabine combined
with filgrastim (G-CSF) primed allogeneic peripheral blood stem cells in patients who
relapsed within 1 year after allogeneic bone marrow transplantation. III. Determine the
effectiveness in reinducing remission in these patients.
OUTLINE: Patients receive decitabine IV for 6 hours every 12 hr for 5 days. Peripheral blood
stem cells (PBSC) are administered 5 days after last dose of decitabine. Donors receive
filgrastim subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to first PBSC
collection. If insufficient number of cells are collected, bone marrow can be harvested for
supplementation. Donor cells should be collected prior to decitabine infusion. Patients
receive filgrastim SQ administered daily starting 1 day after PBSC infusion until blood
counts recover. For GVHD prophylaxis, patients receive cyclosporine IV daily on day -2, then
orally once dose is tolerable. Dose of decitabine is escalated in cohorts of 3-6 patients.
If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then that dose is
declared the maximum tolerated dose. Patients are followed weekly. If none of the first 5
patients survive in remission for more than 100 days, the study will be terminated.
PROJECTED ACCRUAL: At least 15 patients will be accrued for this study over 2 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) Decitabine
Weekly for 1 year
Sergio Giralt, MD
M.D. Anderson Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|